CN102548598A - Delivery device with sensor and one or more cannulas - Google Patents

Delivery device with sensor and one or more cannulas Download PDF

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Publication number
CN102548598A
CN102548598A CN 201080035079 CN201080035079A CN102548598A CN 102548598 A CN102548598 A CN 102548598A CN 201080035079 CN201080035079 CN 201080035079 CN 201080035079 A CN201080035079 A CN 201080035079A CN 102548598 A CN102548598 A CN 102548598A
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member
cannula
base member
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CN 201080035079
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Chinese (zh)
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CN102548598B (en )
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斯特芬·吉尔恩
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犹诺医药有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles
    • A61B5/6849Needles in combination with a needle set
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0406Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412Low-profile patch shaped housings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585Needle inserters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A61M2005/1726Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure the body parameters being measured at, or proximate to, the infusion site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Abstract

The invention concerns a base part for a medication delivery device. The base part is during use fastened to a patient's skin and connected to a cannula part which cannula part is positioned at least partly subcutaneous. The base part is also connected to a sensor unit which can detect one or more components e.g. glucose content in the patients blood. The base part comprises fastening means (15) which fastening means (15) releasably attach the reservoir/delivery part to the base part during use and a first fluid path or means corresponding to a first fluid path from a reservoir permitting a flow of fluid between the reservoir/delivery part and the base part when the reservoir/delivery part is attached to the base part, the first fluid path comprises means (17) for interrupting the fluid flow when the detachable reservoir/delivery part is not attached to the base part (1) and opening the fluid path (19) when the delivery part is attached to the base part (1). The base part (1) also comprises a lower mounting surface (2) and one or more openings (12A, 12C) through which two or more subcutaneous units (7,70) in the form of at least one cannula and at least one sensor part or at least two cannulas extend and it comprises a second fluid path permitting a flow of fluid from the outlet of the first fluid path to an inlet of a subcutaneously positioned cannula (22, 22a, 22b) during use, and a signal path is provided from the reservoir/delivery part to a sensor contact part. The base part is characterized in that the second fluid path is in fluid connection with an end opening of a subcutaneously positioned cannula during use.

Description

具有传感器和一个或多个插管的传送装置[0001] 本发明涉及用于药物传送装置的基座部件。 And a sensor delivery device having one or more cannula [0001] The present invention relates to a base component of the drug delivery device. 该基座部件在使用时紧固至患者的皮肤并且连接至独立的插管部件,该插管部件至少部分地在皮下定位。 The base member is fastened in use to a patient's skin and connected to a separate cannula part positioned at least partially in the subcutaneous cannula member. 该基座部件还连接至传感器单元,该传感器单元能够检测一个或多个成分,例如患者血液中的葡萄糖含量。 The base member is also connected to the sensor unit, the sensor unit capable of detecting one or more components, for example the patient's blood glucose levels. 背景技术[0002] 文献US/2009/0118592披露了(图^C,实例4,第14页)一种医用药物传送装置, 该传送装置包括经皮装置部件以及结合有血糖仪820的储存器单元、连续式血糖仪816以及包括输液计算器的无线远程控制单元830,这些部件共同形成系统802。 [0002] Document US / 2009/0118592 discloses (Fig ^ C, Example 4, page 14) a medical drug delivery device, the delivery device comprising a transcutaneous device and a member of the blood glucose meter 820 incorporates a storage unit , continuous infusion blood glucose meter 816 comprises a calculator and a radio remote control unit 830, which together form a system 802 components. 经皮传感器817 可以形成为经皮装置单元的一部分,并且适于处理和/或传送传感器数据的传感器电子器件形成为储存器单元的一部分。 Transcutaneous sensor 817 may be formed by a portion of the transcutaneous device unit, and adapted to process and / or transmit sensor data to the sensor electronics forms part of the reservoir unit. 传感器可以与经皮装置一起更换,或者独立于经皮装置更换。 Sensor can be replaced with a transcutaneous device, a transdermal device or independent replacement. [0003] 文献US2008/0200897披露了一种输液装置,一体的输液装置以及分析物监控系统。 [0003] Document US2008 / 0200897 discloses an infusion device, an infusion device and one of the analyte monitoring system. 该文献提供了用于药物传送和生理状态监控的模块化组合的几种方法和系统。 The literature provides several methods and systems for the modular combination of medication delivery and physiological condition monitored. [0004] 这些装置都不能用于皮下定位单元(例如插管),并且当传感器定位在一个单个的贴片(patch)或安装表面上时,该传感器可能指向不同方向,并且这些装置都不能在不移除基座部件或贴片(插管是该基座部件或贴片的一部分)的情况下缩回插管。 [0004] These devices can not be used for subcutaneous positioning unit (e.g. a cannula), and when the sensor is positioned on a single patch (Patch) or the mounting surface, the sensor may point in different directions, and these devices are not in without removal of the patch or base member (a base member of the cannula is part of or patch) is retracted cannula. [0005] US2004/0162521披露了一种针装置,其包括壳体、基座部分以及多个针,该基座部分具有适于施加至患者皮肤的安装表面。 [0005] US2004 / 0162521 discloses a needle device comprising a housing, a plurality of pins and a base portion, the base portion having a mounting surface adapted to be applied to the skin of the patient. 每个针包括适于穿透患者皮肤的远侧尖端,并且每个针具有第一位置和第二位置,在第一位置中远端相对于安装表面缩回,并且在第二位置中远端从安装表面伸出。 Each needle includes a distal tip adapted to penetrate the patient's skin, and each needle having a first position and a second position, in the first position the distal end is retracted relative to the mounting surface, and a second position, distal end projecting from the mounting surface. 根据该文献,由于在使用之前和之后,针都垂直于安装表面在其整个长度上缩回,因此安置在患者上的针装置必须具有至少与针长度相当的高度,此外,根据示出的实施例的插管必须为设置有侧入口的硬的自刺入插管。 According to this document, because before and after use, the needle is retracted perpendicular to the mounting surface over its entire length, positioned on a patient needle device must have at least a height corresponding to the length of the needle, in addition, according to the illustrated embodiment Example cannula must be provided with an inlet-side hard self penetrating cannula. [0006] US2008/0004515披露了一种结合有体上贴附式泵的一体式分析物监控系统,所述体上贴附式泵设置有多个插管和传感器组合。 [0006] US2008 / 0004515 discloses a unitary analyte monitoring system incorporating the patch pump body, the pump body is provided with a plurality of patch cannula and sensor combination. 根据该文献的一个实施例,可以将第一插管设置为用于在初始时间段(例如3-4天)中在第一注射位置用于药物的经皮传送。 According to one embodiment of this document, a first cannula can be provided for an initial period of time (e.g. 3-4 days) for the transdermal delivery of the drug in the first injection position. 之后,在一个或多个控制器和注射管理单元的控制和操作下,使第一插管从所述注射位置缩回。 Thereafter, under the control and operation of one or more controllers and injection management unit, the first cannula is retracted from the injection site. 在缩回第一插管之后,在第二注射位置插入第二插管。 After retracting the first cannula, second cannula is inserted into the second injection position. 利用耦接于第二插管的插入装置(例如插入枪)可以将第二插管自动地插入,例如,所述插入装置包括弹簧偏置驱动插入机构。 Using a cannula coupled to the second insertion means (e.g., insertion gun) may be automatically inserted into a second cannula, for example, inserting the insertion device comprises a spring biasing the drive mechanism. 第二插管290安装在与贴附式泵210分隔开的基座部件上,其中第一插管连同所述贴附式泵一起安装。 The second cannula 290 is mounted on a patch pump 210 spaced from the base member, wherein a first cannula mounted in conjunction with the patch pump together. 发明内容[0007] 本发明提供一种包括用于刺入构件的皮下引入的插入装置的组件,其中“刺入构件”理解为针、插管、传感器或类似物。 SUMMARY OF THE INVENTION [0007] The present invention provides an assembly for penetrating the skin member insertion device is introduced, wherein the "piercing members" is understood as a needle, a cannula, a sensor or the like. 在插入刺入构件之前或其插入期间,刺入构件通常保持在这样的位置中,其中在此位置刺入构件不被患者看见,并且在实际地插入刺入构件之前,使用者或患者不能与该刺入构件接触。 During or before inserting the piercing member is inserted, the piercing member is normally held in a position in which the piercing member is not seen in this position the patient, and before the actual insertion of the piercing member, the user or patient can not be the piercing member in contact. [0008] 本发明的目的在于提供一种与可拆卸(detachable)储存器/传送部件结合的基座部件,该基座部件包括:紧固装置,在使用期间,该紧固装置将储存器/传送部件可松脱地(releasably,可解除的)附接至基座部件;以及第一流体路径或装置,该第一流体路径或装置与来自储存器的第一流体路径对应,在储存器/传动部件附接至基座部件时,第一流体路径或装置允许储存器/传送部件和基座部件之间的流体流动,第一流体路径包括用于当可拆卸储存器/传送部件部位未附接至基座部件时中断流体流并且当传送部件附接至基座部件时打开流体路径的装置,基座部件还包括下安装表面和一个或多个开口,两个或更多个皮下单元延伸穿过所述一个或多个开口,所述两个或更多个皮下部件为至少一个插管和至少一个传感器或者至少两个插管的形式;第二流体路径, [0008] The object of the present invention is to provide a detachable (Detachable) a base member storage / transfer member combination of the base member comprising: a fastening means, during use, the fastening means to the reservoir / conveying means releasably (releasably, releasable) attached to the base member; and a first fluid path or means, or the first fluid path means and corresponding to a first fluid path from the reservoir, the reservoir / when the transmission member attached to the base member, or the first fluid path means allows fluid flow between the reservoir / transport member and the base member, comprises a first fluid path when the removable storage / transfer member is not attached portion interrupting the fluid flow is connected to the base member and a fluid path is opened when the transfer member attached to the base member, the base member further includes a lower mounting surface and the one or more openings, two or more extension units subcutaneously through the one or more openings, the two or more components of at least a subcutaneous cannula and the at least one sensor in the form of at least two or cannula; second fluid path, 使用时,所述第二流体路径使得来自第一流体路径出口的流体流动至皮下定位的插管的入口;以及信号路径,设置成从储存器/传送部件达到传感器接触部件,其中在使用期间,第二流体路径与皮下定位的插管的端部开口流体连通。 In use, the second fluid path so that fluid from the first fluid flow path to the outlet of the cannula located subcutaneously inlet; and a signal path, is arranged in contact with the sensor member from the storage / transfer unit has reached, wherein during use, a second end portion of the cannula to the subcutaneous fluid path positioned in fluid communication with the opening. [0009] 连接至第二流动路径的端部开口是在使用期间布置在患者皮肤上方的端部开口。 End is disposed above the patient's skin during the [0009] end connected to the second flow path opening is an opening in use. 根据权利要求1的基座部件的结构使得可以使用软插管,不过也不排除使用硬插管。 The base member structure according to claim 1 makes it possible to use a soft cannula, but does not rule out the use of a hard cannula. 在一些说明性实施例中使用了硬插管,而在一些实施例中使用了软插管,所述软插管通常利用所用的插入针来插入。 Use hard cannula in some illustrative embodiments, the use of a soft cannula, in some embodiments, the soft cannula is usually inserted using an insertion needle used. 具有开口的平坦基座部件使得可以使用单独的插入件,在安装了皮下定位单元之后,该单独插入件可以从基座部件上移除。 A planar base member having an opening such that the insert may be used alone, the individual insert may be removed from the base member after the subcutaneous positioning unit is installed. 第二,由于软壁可能会沿纵向方向移动,或者可能会受制于可能会减小插管内径的流体压力,所以,很难通过柔软且无支撑的插管中的侧面开口(即没有刚性壁支撑软插管的周边)来提供流体路径。 Second, since the flexible wall may be moved in the longitudinal direction, or may be subject to the fluid pressure may decrease the inner diameter of the cannula, it is difficult to support by the side of the cannula soft and non-opening (i.e., without a rigid wall surrounding support soft cannula) to provide a fluid path. [0010] 端部开口的定义:插管由细长管形件制成,该细长管形件由柔软且有弹性的材料(例如弹性体)制成,或者由坚硬且有刚性的材料(例如金属或硬塑料)制成,并且该细长管状件可以具有两个端部开口:入口和出口。 [0010] defined end opening: an elongated tubular cannula is made of a member, the elongated tubular member made of a soft and flexible material (e.g. elastomer), or by a hard and rigid material ( such as a metal or hard plastic), and the elongate tubular member may have two open ends: an inlet and an outlet. 如果插管是喷洒器型的,则该插管也可以具有一个或多个侧面出口。 If a sprinkler type cannula, the cannula may also have one or more sides of the outlet. 如果插管的一个端部设置有具有扩展的直径的部件,例如,通常在将模制插管紧固在硬质材料的保持体内部时会使用的轮毂,则不将该轮毂视为该细长管状件的部件。 If one end of the cannula is provided with an extended member having a diameter of, for example, generally in the wheel molding the cannula holder is fastened in the interior of the hard material will be used in a hub, the hub is not considered that a fine member of the long tubular member. [0011] 根据基座部件的一个实施例,第一流体路径可以由作为基座部件的一部分的连接针或者由作为储存器/传送部件的一部分的连接针以及在其他部件上的用于该连接针的对应入口形成,该入口通常由保护密封膜保护。 [0011] According to one embodiment of the base member, the first fluid path may be formed as a connector pin or a portion of the base member by a connection pin as part of the storage / transfer means for the connection and on the other member an inlet formed corresponding to the needle, the inlet is typically protected by a protective sealing film. [0012] 由于覆盖着储存器出口的至少一个密封膜是自封闭的,所以当传送部件与基座部件分离并且移动远离基座部件时,第一流体路径中断,并且当连接针从膜缩回后,所述膜会防止流体从储存器流动至第二流体路径。 [0012] Since the sealing membrane covers the at least one outlet of the reservoir is self-closing, so that when the transfer member and the base member are separated and moved away from the base member, a first fluid path is interrupted, and when the connecting needle is retracted from the film after, the film may prevent fluid flow from the reservoir to the second fluid path. 当然,这只是将同一储存器安装几次时的情况。 Of course, this is just the same storage installation at times. 通常,保护膜既覆盖储存器的出口,也覆盖基座部件的第二流体路径的入口。 Typically, the protective film may cover the outlet of the reservoir, also covers the inlet of the second fluid path of the base member. [0013] 根据基座部件的一个实施例,第二流体路径包括:被垫圈环绕的一个表面开口,该垫圈具有中心开口,流体可以流过该中心开口;以及被硬光滑表面环绕的第二表面开口。 [0013] In one embodiment, the second fluid path includes a base member according to: a surface of the gasket around the opening, the gasket having a central opening, fluid can flow through the central opening; hard smooth surface and a second circumferential surface opening. 第二流体路径包括可移动部件,该可移动部件具有至少两个不同的位置,每个位置均设置有将第一流体路径连接至给定插管的独立的第二流体路径。 The second fluid path includes a movable member, the movable member having at least two different positions, each provided with a first fluid path independent of the second fluid path is connected to a given cannula. [0014] 根据基座部件的一个实施例,传送部件具有相对于基座部件的多个紧固位置,并且每个位置均形成的彼此都不相同的第二流体路径。 [0014] are not identical to each other with respect to the plurality of fastening position of the base member, and each position of the second fluid path formed in accordance with one embodiment, the transmission member having a base member. [0015] 根据基座部件的一个实施例,插管部件中的一个或多个包括硬质刚性材料的本体,该本体具有流体入口和流体出口,本体的流体出口与插管的入口端对应。 [0015] According to one embodiment, the cannula member comprising one or more bodies of a hard rigid material of the base member of the embodiment, the body having a fluid inlet and a fluid outlet, the fluid outlet and the inlet end of the cannula body corresponds. 插管部件的插管可以例如由柔软且有弹性的材料(例如弹性体)制成,并且插管部件的硬质本体可以设置有顶部开口。 Intubation member may be made of soft and flexible material (e.g. elastomer), the cannula and the rigid body member may be provided with a top opening. [0016] 在插管是柔软且有弹性的情况下,必须利用插入针插入该插管,该插入针通常穿过硬质本体的顶部开口,g卩,与管状插管相对设置并且在管状插管的延伸区域内的开口,该顶部开口由隔膜(即自封闭膜)保护。 [0016] In the cannula is soft and flexible, the insertion needle must be inserted by using the cannula, the needle is typically inserted through the top opening of the body of hard, g Jie, and disposed opposite the tubular cannula is inserted in the tubular an opening extending in the region of the tube, the top opening by the diaphragm (i.e., self-sealing membrane) protection. 根据该实施例,基座部件包括:连接装置,该连接装置用于与每个开口和位置相关的插入件;以及紧固装置,该紧固装置适用于紧固在将基座部件安装在患者皮肤上之后插入的每个插管或插管部件或传感器部件。 According to this embodiment, the base member comprising: a connecting means for the connecting means associated with each opening and the position of the insertion member; and a fastening means, the fastening means suitable for fastening the base member is mounted in the patient each member or cannula or cannula after insertion of the sensor member on the skin. 例如,在第0天(day 0,第0个使用日)将一个插管和一个传感器例如同时穿过开口插入,并且附接至基座部件, 通常,在制造过程期间通常将至少一个插入件附接至基座部件,并且当使用者收到包括基座部件的装置时,所述装置包括具有安装表面的基座部件以及可松脱地附接至基座部件而处于待使用状态的插入件。 For example, on day 0 (day 0, using the 0th day) to a sensor, such as a cannula and simultaneously inserted through the opening, and attached to the base member, typically, typically at least one insert during the manufacturing process attached to the base member, and when the user receives the device comprising a base member, said device comprising a base member having a mounting surface and may be releasably attached to the base member to be used in the state inserted pieces. 在插入插管和/或传感器之后,用于插入件的附接装置使得使用者可以例如连同插入件的剩余部分一起来移除插入针。 After insertion of the cannula and / or sensor, attachment means for allowing the user to insert, for example, along with the remaining portion of the insert insertion needle is removed together. 因此,在使用期间不必安装刺入针,反而是在使用期间,只在皮下安装了软插管或软传感器部件,这对患者来说更舒适。 Thus, during use of the injection needle need not be installed, but during use, only the soft cannula or a sensor member mounted on the soft skin, which is more comfortable for the patient. [0017] 本发明可以提供包括用于刺入构件的皮下引入的插入装置的组件,其中“刺入构件”理解为针、插管、传感器或类似物。 [0017] The present invention may provide a component insertion means comprise a piercing member is introduced subcutaneous, wherein "piercing members" is understood as a needle, a cannula, a sensor or the like. 通常,在插入刺入构件之前或插入期间,刺入构件保持在这样的位置中,在该位置患者看不见所述刺入构件并且在实际插入刺入构件之前使用者或患者不能与该刺入构件接触。 Typically, during or prior to inserting the piercing member is inserted, the piercing member is held in such a position, the position of the patient and the user can not see the piercing member piercing or not the patient is actually inserted before the piercing member the contact member. [0018] 本发明的目的在于提供一种包括或可连接至要在皮下设置的至少一个插管的基座部件,该基座部件还包括[0019]-接触或安装表面,用于将基座部件紧固至患者皮肤,[0020]-紧固装置G),在使用期间将药物供应装置(medication supply) (6)或类似物连接至基座部件,[0021]-传感器和/或发射器单元,[0022] 其中,至少一个插管附接至或包括缩回装置,该缩回装置使得能将至少一个插管从其皮下使用位置移走并且将该插管缩回至不与患者皮肤接合的位置。 [0018] The object of the present invention is to provide a comprising or connectable to the base member to at least a set of subcutaneous cannula, the base member further comprises [0019] - or the contact mounting surface for the base member secured to the skin of the patient, [0020] - fastening means G), connected during use to a drug supply device (medication supply) (6) to the base member, or the like, [0021] - a sensor and / or transmitter means, [0022] wherein the at least one cannula or attached to a retraction means comprises, means which makes it possible to retract the at least one cannula and removed from its subcutaneous position to retract the cannula and the skin of the patient is not engaged position. 基座部件可以包括或可连接至至少两个插管。 Or the base member may comprise at least two connectable to the cannula. [0023] 根据一个实施例,该至少两个插管以相互之间至少为IOmm的距离I1设置,通常, 相互之间的距离I1为2至少0mm。 [0023] According to one embodiment, the at least two mutually cannula at a distance of at least IOmm I1 provided, typically, a distance I1 between each of at least 2 0mm. [0024] 根据一个实施例,基座部件包括作为基座部件的一部分的连接部件,该连接部件包括至少具有一个入口和至少一个出口的流体连接(fluid connection),其中所述入口形成到达药物供应装置或类似物的流体连接,并且第二开口形成到达插管部件的流体连接。 [0024] According to one embodiment the supply of drugs, the base member comprises a connection member as part of the base member, the connecting member having at least one inlet and at least one outlet fluid connection (fluid connection) embodiment, wherein the inlet is formed arrival fluid connection means or the like, and the second opening formed in the fluid reaches the cannula member is connected. 连接部件相对于安装表面是固定的,并且基座部件进一步包括可移动部件,该可移动部件可以相对于连接部件移动,并且安装表面包括至少两个独立的流体路径,其中一个流体路径将流体引导至第一插管,并且第二流体路径将流体引导至第二插管。 The connecting member is fixed relative to the mounting surface, and the base member further includes a movable member, the movable member can be moved relative to the connecting member, and the mounting surface of the fluid path comprises at least two separate, wherein a fluid path guiding the fluid to the first cannula and the second fluid path directs the fluid to the second cannula. 基座部件可以包括导向装置,其中每个导向装置将皮下设置的部件引导至其完全向前的(即皮下的)位置。 The base member may comprise a guide means, wherein each guide member disposed subcutaneously directed to its fully forward (i.e., subcutaneous) position. 进一步,在使用期间,导向装置可以引导每个皮下定位的部件,以沿着自平行于患者皮肤表面的方向偏移了15-85°的方向、在安装表面附接的区域处切穿患者皮肤。 Further, during use, each guide member guiding means can be located subcutaneously, in a direction parallel to the skin surface of the patient from the offset direction of 15-85 °, in the region of the mounting surface attached to cut through the patient's skin . [0025] 根据一个实施例,插管部件中的至少一个是独立部件,在基座部件能够将流体传送至患者之前,该独立部件必须插入并且紧固至基座部件。 [0025] According to one embodiment, the cannula member, at least one independent member, fluid can be delivered to the patient prior to the base member, the member must be independently inserted and fastened to the base member. [0026] 根据一个实施例,传感器部件是独立单元,在能够建立期望参数的测量之前,该传感器部件必须插入并且紧固至基座部件。 [0026] According to one embodiment, the sensor member is a separate unit, prior to measuring a desired parameter can be established, the sensor member must be inserted and secured to the base member. [0027] 根据一个实施例,传感器部件测量葡萄糖或与葡萄糖对应的分析物,并且被传送穿过至少一个插管的药物是胰岛素。 [0027] According to one embodiment, the sensor means measures glucose or glucose corresponding analyte and is transmitted through at least one cannula medicament is insulin. [0028] 根据本发明的另一方面,本发明涉及包括根据前述任一权利要求所述的基座部件以及可附接至患者并且可以与基座部件一起供患者使用的传送装置的系统,该传送装置包括含有流体的储存器、用于将流体从储存器转移至基座部件的泵送装置、以及电源,该电源向泵送装置以及向基座部件的传感器提供动力。 [0028] According to another aspect of the present invention, the present invention relates to a base member according to any one of the preceding claims, and may be attached to the patient and may be used in the patient transfer device together with the base member of the supply system, the transfer means comprises a reservoir containing a fluid for transferring fluid from the reservoir to the pumping means of the base member, and a power source that provides power to the sensor base member and the pumping device. [0029] 本发明的另一目的是提供一种可连接至独立插管部件的基座部件并且包括用于接纳独立插管部件的装置,该基座部件包括[0030]-接触表面,用于将基座部件紧固至患者皮肤,[0031]-紧固装置,在使用期间将药物供给装置(6)或类似物连接至基座部件,[0032]-作为基座部件的一部分的连接部件,该连接部件包括具有至少第一和第二开口(即入口和出口)的流体连接,其中第一开口形成到达药物供给装置或类似物的流体连接, 并且第二开口形成到达独立插管部件的流体连接,该基座部件可连接至或包括传感器单元,并且其中,所述连接部件是刚性的,并且流体连接的每个开口设置有密封件或适于与相邻部件的对应密封件配合。 [0029] Another object of the present invention is to provide a base member coupled to an independent member of the cannula and the cannula comprises means for receiving an independent member, the base member comprises [0030] - the contact surface, for the base member is fastened to the skin of the patient, [0031] - fastening means, during use of the medicine supply apparatus is connected (6) to the base member, or the like, [0032] - the connection member as part of the base member , the connecting member comprises at least a first and a second opening (i.e., the inlet and outlet) of the fluid connection, wherein a first opening is formed reaching the medicine supply apparatus or the like connected to the fluid, and the second opening forming member reaches the separate cannula fluid connection, the base member may be coupled to or includes a sensor unit, and wherein said connecting member is rigid, and is fluidly connected to each of the openings is provided a seal or a sealing member adapted to cooperate with a corresponding adjacent member. [0033] 定义[0034] 本文中所用的“平行”或“基本平行”是指沿着相对于第一或参考平面或方向限定的方向、平面、物体或类似物的第二移动,该参考平面或方向具有被限定为角度α =0° 的方向;并且第二平面或方向从第一或参考方向α偏移,最大偏移士10°,通常不超过士5°。 [0033] Definitions [0034] As used herein, "parallel" or "substantially parallel" refers to the first direction with respect to the reference plane or direction or defining a second plane of movement, or the like of the object, the reference plane or direction is defined as having an angle α = 0 ° direction; [alpha] and the second plane or direction or shifted from the first reference direction, the maximum deflection disabilities 10 °, usually not exceed ± 5 °. [0035] 在本申请的上下文中,“水平的”或“基本水平的”表示沿着一个方向、方向、平面、 物体以及类似物的移动是水平的或基本水平的,平行于或基本平行于如上所限定的患者皮肤表面。 [0035] In the context of the present application, or "substantially horizontal", "horizontal" means a direction along the moving direction, the plane, and the like of the object is horizontal or substantially horizontal, parallel or substantially parallel to as defined above skin surface of the patient. 例如,紧固插入装置的基座部件可以是水平的,或基本水平的,平行或基本平行于皮肤。 For example, the base member is inserted into the fastening means may be horizontal or substantially horizontal, parallel or substantially parallel to the skin. [0036] 如本文中所用的“垂直的”或“基本垂直的”是指沿着相对于参考平面或方向限定的沿方向、方向、平面、物体或类似物的第二移动,该参考平面或方向具有角度β =0°的位置或方向;并且第二平面或方向自第一参考角度β偏离了80-100°之间的角度,通常在85-95° 之间。 [0036] As used herein, "vertical" or "substantially perpendicular" refers to the reference plane, or along a direction defined direction, a second movement direction, plane, object or the like, or the reference plane a direction having an angle β = 0 ° position or direction; and a second plane or direction deviates from the first reference angle beta] angle between 80-100 °, typically between 85-95 °. [0037] 在本申请的上下文中,“横向的”或“基本横向的”可以用于与如上所定义的垂直的或基本垂直的交换使用。 [0037] In the context of the present application, the "transverse" or "substantially transverse" it may be used with a vertical or substantially vertical exchange used as defined above. [0038] “装置”:如本文中所用的,该表述“装置”可以包括一个或多个装置。 [0038] "means": for example, the expression "device" as used herein, may include one or more devices. 这无关紧要, 如果根据语法,涉及所述装置的动词表示单数或复数。 It does not matter, if the singular or plural according to the syntax, the device relates to the verb. 附图说明[0039] 现在参照附图详细说明本发明的实施例,其中相同的标号表示不同附图中的对应部件。 Exemplary embodiments of the present invention will be described [0039] Referring now to the drawings in detail, wherein like reference numerals designate corresponding parts in the various figures. [0040] 图IA示出了根据本发明的基座部件的一个实施例,该基座部件设置有用于插管部件的开口和用于传感器部件的开口。 [0040] FIG IA shows an embodiment of a base member of the present invention, the base member is provided with an opening for the cannula and an opening member for the sensor member. [0041] 图IB示出了与图IA中基座部件的实施例对应的传送此部件的一个实施例。 [0041] FIG IB illustrates an embodiment corresponding to the transmission and the base member of FIG. IA is a member of the embodiment of this embodiment. [0042] 图2示出了结合有用于插入传感器部件的插入件的、如图1中的基座部件那样的相同的实施例。 [0042] FIG. 2 shows incorporating the same in the base member 1 as shown for insertion of a sensor member according to an embodiment of the insert. [0043] 图3示出了传感器部件的一个实施例,其可以与图1和图2中示出的基座部件的实施例一起使用。 [0043] FIG. 3 shows one embodiment of the sensor member, which may be used with the embodiment 1 and the base member shown in FIG. 2 FIG. [0044] 图4A-图4B示出了图1中基座部件的实施例的两个视图,该基座部件同时具有插管部件和设置在每个开口中的传感器部件。 [0044] FIGS. 4A- 4B illustrate two views of an embodiment of a base member of FIG. 1, while the base member having a cannula member and a sensor member disposed in each opening. [0045] 图5A-图5C示出了图1、图2和图4中的基座部件的实施例,其中传感器部件已经插入皮下,并且插入件仍然留在基座部件上的位置中。 [0045] FIG. 5A- FIG. 5C illustrates an embodiment of a base member in FIG. 2 and FIG. 4, wherein the sensor member has been inserted subcutaneously, and the insert remain in position on the base member. [0046] 图6A-图6B示出了图1中的基座部件与传送部件在一起的实施例。 [0046] FIGS. 6A- 6B shows the base member and the conveying member in Example 1 together embodiment of FIG. 图6C示出了可以与这种结合的传送装置一起使用的控制器。 6C shows a controller for use with a delivery device may be combined with such. [0047] 图7示出了如图4A-图4B中所示的那样包括传感器的基座部件的相同实施例,该图进一步描绘了在使用期间传送部件的触点位置。 [0047] FIG. 7 shows the same embodiment as the base member comprises a sensor shown in FIG. 4A- 4B, the figure further illustrates the position of the transfer member in contact during use. [0048] 图8示出了与图7所示那样的包括传送装置的触点71a的相同实施例,其中传送装置处于预使用位置中。 [0048] FIG. 8 shows the same embodiment includes the contacts 71a of the delivery device as shown in Figure 7, wherein the transfer means in a pre-use position. [0049] 图9示出了与图7所示那样的包括传送装置的触点71a的相同实施例,其中传送装置处于使用位置中。 [0049] FIG. 9 shows the same embodiment includes the contacts 71a of the delivery device as shown in Figure 7, wherein the transfer means is in the position of use. [0050] 图10示出了具有两个独立插管和一个皮下设置的传感器的基座部件的实施例。 [0050] FIG. 10 illustrates an embodiment of a base member having two independent sensor and a subcutaneous cannula disposed of. [0051] 图11描绘了如何使用图10中的装置。 [0051] FIG. 11 illustrates how the apparatus 10 used in FIG. [0052] 图12示出了从上方观看的具有两个插管的基座部件的实施例。 [0052] FIG. 12 illustrates an embodiment of a base member having two cannula viewed from above. [0053] 图13示出了从侧面观察的如图12所示的基座部件相同的实施例。 [0053] FIG. 13 shows the base member 12 shown in FIG viewed from the side of the same embodiment. [0054] 图14示出了设置有用于插管的两个独立接纳位置的基座部件的实施例。 [0054] FIG. 14 shows an embodiment provided with a base member for receiving two separate positions of the cannula. [0055] 图15示出了基座部件的一个实施例的侧视图,其具有用于插管的两个独立位置以及安装在这两个位置的每一个中的传送部件。 [0055] FIG. 15 shows a side view of one embodiment of a base member, which has two separate positions for the cannula and a transmitting member mounted on each of these two positions. [0056] 图16示出了与用于插管的可松脱位置结合的基座部件的一个实施例。 [0056] FIG 16 shows a base member releasably combined with the cannula in a position for the embodiment. [0057] 图17示出了基座部件的一个实施例,其中通过推动共同部件确立了流体路径。 [0057] FIG. 17 shows one embodiment of a base member, wherein the member together by pushing the fluid path established. [0058] 图18A-图18B示出了包括具有可滑动单元的第二流体路径的基座部件的一个实施例。 [0058] FIG. 18A- FIG. 18B shows a base member comprising a second fluid path having a slidable unit according to one embodiment. 具体实施方式[0059] 图IA示出了基座部件1的一个实施例,该基座部件包括用于插管部件7的一个通孔12A,以及用于传感器部件的一个通孔12C。 DETAILED DESCRIPTION [0059] FIG IA illustrates a base member 1 of the embodiment, the base member comprising. 12A, a through hole 12C and a sensor means for the cannula part 7 in a through hole. 插管部件7安装在在图1的通孔中,并且可以看见插管部件7的设置有中央定位的隔膜的顶部表面。 Cannula part 7 is mounted in the through-hole in FIG. 1, and can see the top surface of the cannula part 7 is provided with a centrally located septum. 基座部件1包括具有下侧的平坦表面(在使用期间,该下侧与患者皮肤接触),并且所述基座部件设置有安装表面;通常,安装表面由压力粘结层构成,该压力粘结层焊接至基座部件1的下侧或者直接粘接至基座部件1的下侧。 1 comprises a flat base member having a lower surface (during use, the lower side of the skin contact with the patient), and the base member is provided with a mounting surface; Typically, the mounting surface of the adhesive layer is composed of a pressure, the pressure adhesive junction layer welded to the lower side of the base member 1, or directly adhered to the lower side of the base member 1. 基座部件1的上侧包括紧固装置15,所述紧固装置为两个伸出部件的形式,在使用期间,该该紧固装置15与纵向升高的导向装置4结合而将传送部件8保持在位。 An upper base member 15 comprises a fastening means, the fastening means is in the form of two projecting members, during use, the fastening means 154 of the binding member to the transfer of the longitudinal guide means elevated 8 in place. [0060] 基座部件能够例如基于患者血液中葡萄糖的测量结果来传送胰岛素。 [0060] The base member can be, for example, based on measurements of the patient's blood glucose to insulin transport. [0061] 图1中未示出传感器部件,即基座部件1处于这样的状态(预使用)中,在该状态中传感器还没有定位在开口12C中。 In [0061] FIG. 1 is not shown sensor means, i.e., the base member 1 is in a state (pre-use), and in this state has not been positioned in the opening sensor. 12C. 根据图1的实施例,传感器开口12C设置有用于插入件的附接装置,所述附接装置为相对于基座部件1的平坦表面竖直立起的圆柱形壁12D的形式。 According to the embodiment of FIG. 1, sensor opening 12C is provided with means for attachment of the insert, the attachment means is in the form of a flat surface of the base member with respect to a vertical upright of the cylindrical wall 12D. 由于传感器部件插入件的出口端紧密地围绕圆柱形壁12D配合,所以当定位传感器部件时,该直立或伸出的圆柱形壁用作用于传感器部件插入件的附接装置。 Since the sensor member is inserted into the outlet end of the member surrounding the cylindrical wall 12D is tightly fitted, so that when the sensor member is positioned, the projecting or upstanding cylindrical wall is used as the sensor means for attaching the insert member. 用于定位传感器部件的附接装置12D可以具有其他形状,例如附接装置12D可以具有一个或多个直立杆或棒的形式,或者是进入基座部件1的表面的一个或多个开口的形式。 Attachment means for positioning the sensor member 12D may have other shapes, e.g. 12D attachment means may have the form of one or a plurality of upstanding rods or bars, or a surface or into the base member 1 in the form of a plurality of openings . [0062] 用于传感器的开口12C相对于用于插管部件7的开口12A设置在表面板1的相对端。 [0062] 12C opening for the sensor relative to the surface of the end plate 1 of the opening 12A for the cannula part 7 is provided. 这可以确保药物输入和该药物的生理效果的测量结果之间的干扰尽可能小。 This ensures that the interference between the drug and the input measurement results of physiological effects of the drug as small as possible. 在两个点(即药物流入点和相对于药物分解测量生理效果的点)之间的必要最小距离取决于药物种类和供应至患者的药物浓度以及这两个点中的每一个在皮下定位的深度。 Necessary minimum distance at two points (i.e., pharmaceutical drugs with respect to the inflow point and the decomposition point measuring physiological effect) between the drug depends on the kind and the concentration of drug supplied to the patient's skin and each of the two points located depth. 通常,这两个点之间的距离为至少20mm是可接受的。 Typically, the distance between the two points is at least 20mm is acceptable. [0063] 图IB示出了与图IA中的基座部件1对应的传送部件8。 [0063] FIG IB illustrates a carrier member 8 in Fig. IA corresponding to a base member. 从下侧能够看见如何将储存器6定位在传送部件8中,并且能看见如何将与基座部件1的紧固装置15对应的两个相对定位的释放手柄9设置在传送部件8的边缘处。 It can be seen from the lower edge of how the reservoir 6 is provided in the transfer member 9 is positioned in 8, and can see how the release handle and the base member 15 corresponding to the two opposite fastening means 1 is positioned in the transfer member 8 . 进一步可以看见的是,与基座部件上的纵向升高导向装置4相对应的纵向轨道。 Further it can be seen that the four longitudinal track corresponding to longitudinal raised guiding means on the base member. 传送部件8的对应装置可以沿着导向装置4的金属衬里5滑动,所述导向装置为沿纵向方向的升高平台4的形式。 Means for transmitting a corresponding member along the guide means 8 may be a metal lining 5 of the slide 4, in the form of means for the longitudinal direction of the raised platform 4 of the guide. 金属衬里5可以例如是磁性的,并且如果传送部件8设置有对应的磁性部件,则在安装传送部件8期间,所述金属衬里很容易“抓住”传送部件8。 Metal lining 5 may, for example be magnetic, and if the transmission member 8 is provided with a corresponding magnetic member, the transmission member 8 during installation, the metal liner is easy to "catch" the transfer member 8. 当传送部件8到达其工作位置,这两个释放手柄9分别与紧固装置15接合,所述紧固装置为从基座部件1的上表面伸出的两个部件的形式。 8 when the transfer member reaches its working position, two release handles 9 engage respectively with the fastening means 15, the fastening means is in the form of two members extending from the surface of the base member 1. 当传送部件8处于其工作位置中时,通过释放手柄9沿所有水平方向将所述传送部件锁定。 When its operating position in the conveying member 8, the transfer by the release handle locking member 9 in all horizontal directions. 该锁定机构使得可以根据需要经常性地将传送部件紧固至基座部件或者将传送部件从基座部件释放,即,单次使用的基座部件可以与多次用的传送部件结合。 The locking mechanism makes it possible to regularly transmit the necessary fastening member to the base member or the base member is released from the conveying member, i.e., a single base member used in conjunction with the transfer member may be used several times. [0064] 这两个释放手柄9形成为S-形的带,其中所述带的一端以类似铰接的方式紧固至传送部件8的壳体,并且S-形的第一弯曲部稍微延展了传送部件的壳体的外表面,而第二弯曲部是自由的(即,未附接至传送部件8的壳体),并且第二弯曲部设有钩形形状,该钩形形状可以围住从基座部件1的远侧表面伸出的紧固装置15合拢。 [0064] The two release handles 9 are formed as S- shaped belt, wherein the belt end fastened to the housing in a similar conveying member 8 articulated manner and S- shaped first curved portion slightly extended the conveying an outer surface of the housing member and the second curved portion is free (i.e., not attached to the housing of the conveying member 8), and the second curved portion is provided with a hook shape, the hook shape may enclose fastening means projecting from the distal surface 15 of the base member 1 is closed. 当传送部件8被锁定至基座部件1时,两个释放手柄9都围住紧固装置15合拢,当传送部件8从基座部件移除时, 将两个相对的释放手柄9推在一起,从而使释放手柄9的钩形部件从伸出部件释放,并且可以使传送部件8向后(即,沿着远离插管部件7的方向)移动,并且沿此方向从基座部件上移走。 When the transfer member 8 is locked to the base member 1, two release handles 9 are folded encloses the fastening means 15, when the transfer member is removed from the base member 8, the two opposite release handles 9 pushed together so that the release handle extends from the hook member 9 of the release member and the transfer member 8 can be rearwardly (i.e., in a direction away from the cannula member. 7), and removed from the base member along the direction . [0065] 图IB也从上方示出了该传送部件。 [0065] FIG IB also showing the transfer member is shown from above. [0066] 在图IA和图IB中,不能看见连接部件3中的入口,例如来自储存器6的药物可以进入该入口,通常,该入口由膜保护,以防止微生物污染。 [0066] In the FIG. IA and FIG. IB, can not see the inlet member 3 is connected, such as a drug from the reservoir 6 can enter the inlet, typically, the inlet is protected by a membrane, to prevent microbial contamination. 根据一个实施例,连接部件3设置有连接针(由于该连接针设置在泡形膜的后面,故未示出)以及泡形自封闭膜17,并且储存器6可以设置有泡形自封闭膜。 According to one embodiment, the connection member 3 is provided with a connecting needle (since the connection pin is disposed behind the bulb-shaped film, and therefore not shown) and a bubble shaped self closing membrane 17 and the reservoir 6 can be provided with a bubble shaped self closing membrane . 因此,确立了将药物(例如胰岛素或营养补给)从储存器传送至连接部件3的流体路径。 Thus, to establish a fluid path to the drug (e.g. insulin or supplements) transferred from the reservoir to the connecting member 3. 由于这两个部件都设置有自封闭膜,因此能够使这两个单元相互独立,并且稍后再重新连接这两个部件,而不需要连接部件3,从而不会使使患者受到污染。 Since these two members are provided with a self closing membrane, thus enabling the two units independently of each other, and then restore the connection of these two parts, without the connecting member 3, so as not to cause contamination of the patient. [0067] 本装置特别针对作为软针插管所知的插管子群(subgroup)的使用,并且这些软针插管具有范围广泛的应用,例如用于自动药物传送装置中,例如胰岛素传送装置。 [0067] The present device is particularly known as a soft cannula against the needle cannula subgroup (subgroup) is used, and the soft needle cannula having a wide range of applications, for example in an automatic drug delivery device, an insulin delivery device e.g. . 总体来说,软针插管比其他插管更有弹性并且更柔软。 Overall, the soft cannula needle cannula and softer than other more flexible. [0068] 通常,软针插管与引入针(introducer needle) 11—起使用,其中该针用于刺穿屏障到达身体(例如皮肤)并且帮助引入插管。 [0068] Generally, the introducer needle and the soft needle cannula (introducer needle) 11- used together, wherein the needle is used to puncture the barrier to the body (e.g., skin) and helps the introduction cannula. 在将插管引入至体腔内之后,将该针移除。 After the cannula is introduced into a body cavity, the needle is removed. 软针插管留在体腔中达到期望的时间段,在该期望时间段内软针插管用作用于药物传送的装置。 Soft needle cannula left in the body cavity to achieve a desired period of time, the period of time desired soft needle cannula for use as a drug delivery device. 在使用结束之后,通过简单的抽出就可将软针插管从体腔中移除。 , The soft needle cannula can be removed from the body cavity after the end of use by a simple extraction. [0069] 通常,软针插管包括管形挠性部件(flexible part)和毂(hub)。 [0069] Generally, the soft needle cannula comprises a flexible tubular member (flexible part) and the hub (hub). 管形挠性部件适于插入患者体内,并且使得将流体传送至体腔或者从体腔传送流体更为便利。 The flexible tubular member adapted for insertion into a patient, and causes the fluid to the body lumen, or more convenient to transfer fluid from the body cavity. 管形部件必须是有弹性,以便使得插管的载体(例如患者)可以移动而不会有严重的不舒适感。 The tubular member must be flexible, so that the cannula carrier (e.g., a patient) may be moved without the severe discomfort. 不过,管形件的弹性不必大到使其形成扭结的程度,这种扭结可能会中止药物传送。 However, the resilient tubular member is not necessarily large extent to form kinks, such kinks may be aborted drug delivery. 所述毂是管形部件上的连接装置,所述毂适于将管形部件连接至药物传送装置、连接至流体收集容器或连接至另一连接装置(例如,第二个毂)。 The hub is the connecting means on the tubular member, the hub member adapted to be connected to a tubular drug delivery device, connected to the fluid collecting container or to another connecting device (e.g., a second hub). 优选地,软针插管由这样的材料构成,当承载体移动时,该材料的挠性足以弯曲,并且该材料又足够刚性以避免扭结而中断药物供应。 Preferably, the needle cannula is made of soft material such that when the carrier moves, the bending flexibility of the material is sufficient, and the material being sufficiently rigid to avoid kinking and interrupting the supply of drugs. 进一步,该材料必须与医疗使用相容,即对皮肤的刺激必须保持在最小限度,作为无毒的材料,该材料必须不会在体内分解,等等。 Further, the material must be compatible with medical use i.e. irritation of the skin must be kept to a minimum, as a non-toxic material, the material must not decomposed in vivo, and the like. 热塑性弹性体(TPE)就是能够满足这些要求的一种材料。 Thermoplastic elastomer (TPE) is a material that can meet these requirements. 这种可用弹性体的实例有:聚酯醚、E⑶EL、基于TPE的苯乙烯、基于TPE的石蜡、 基于TPE的聚氨酯、基于TPE的酯、基于TPE的氨基(amid)、聚烯烃及硅橡胶。 Examples of such usable elastomers are: polyester ethers, E⑶EL, styrene based TPE, paraffin-based TPE, urethane based TPE, ester based TPE, amino-based TPE (AMID), a polyolefin and silicone rubber. 在一个优选实施例中,该材料选自由聚丙烯、C-FLEX™、C-FLEX™和聚丙烯的混合物、LUPOLEN™ 1840H、 LUP0LENtm3020D、PELLETHAN™2363-75D、PELLETHANEtm2363-55D、TEC0THANE™ 和CARB0THANE™ 组成的组。 In a preferred embodiment, the material is selected from the group consisting of a mixture of polypropylene, C-FLEX ™, C-FLEX ™ and polypropylene, LUPOLEN ™ 1840H, LUP0LENtm3020D, PELLETHAN ™ 2363-75D, PELLETHANEtm2363-55D, TEC0THANE ™ and CARB0THANE ™ thereof. [0070] 根据一个实施例,插管部件可包括硬质毂或本体,所述毂或本体设置有插管和前伸出部(protruding front),该前伸出部具有设有开口的平坦表面。 [0070] According to one embodiment, the cannula member may include a rigid body or a hub embodiment, the hub is provided with a cannula or body and the front projecting portion (protruding front), the front projecting portion has a flat surface provided with an opening . 插管部件的前伸出部不需要是平坦的;实际上,该前伸出部可以具有任意需要的形状,只要其能够在连接部件3 上形成面向插管部件的对应表面。 A cannula member extending front portion need not be flat; in fact, the front protruding portion may have any desired shape, as long as the corresponding facing surface of the cannula member which can be formed on the connecting member 3. 该前伸出部可以以这样的方式倾斜,即,插管部件上部(即,远端)的横截面大于该前伸出部的近端(即,在插入之后最接近患者的端部)处的横截面。 The front projecting portion may be inclined in such a manner, i.e., an upper cannula member (i.e., distal end) of larger cross section than the proximal end of the projecting front portion (i.e., an end portion closest to the patient after insertion) at Cross-section. 前伸出部的开口是入口或出口,流体可以通过该开口进入或离开插管部件。 Projecting portion of the front opening is an inlet or outlet, fluid may enter or leave the cannula member through the opening. 所述本体进一步设置有顶部开口,该顶部开口可以由自封闭膜覆盖。 The body further is provided with a top opening, the top opening can be covered by a self closing membrane. 由于顶部开口面向与周围环境接触的外表面,因此该顶部开口需要某种入口保护。 Since the top opening facing the outer surface in contact with the surroundings, so that the top of the inlet opening need some protection. 如果插管22是软插管,当插入插管部件时,主要使用顶部开口。 If the cannula 22 is a soft cannula, the cannula when the insertion member is mainly used at the top opening. 插管是软的表示插管由相对软的材料制成并且该插管不能靠自身刺入患者皮肤,在这种情况下,当插入插管时,有必要使用相对硬质材料的尖头插入针, 并且该尖头针可插入穿过顶部开口,经过插管部件本体内的内部空穴(inner hollow),并且进一步经过插管的整个长度,以这种方式插入针的尖头端自中空插管的开口端刺出。 The cannula is a soft cannula made showing relatively soft material and the cannula can pierce skin of a patient on its own, in which case, when the cannula is inserted, it is necessary to use a relatively hard material tip insert needle, and the needle tip may be inserted through the top opening, through the cannula member internal cavity (inner hollow) body, and further through the entire length of the cannula, the insertion needle in such a manner from the tip end of the hollow the open end of the cannula thrusts. 在插入之后,即,在插管被在皮下或者经皮设置在患者体内之后,接着缩回插入针,并且将插管留在患者体内。 After insertion, i.e. the cannula is arranged subcutaneously or percutaneously after the patient, then the insertion needle is retracted and the cannula left in the patient. 插管部件还设置有紧固装置,所述紧固装置的形式可以为一系列向外的钩,这些钩可挠曲地(flexibly)紧固至本体,以这种方式这些钩能够向内且朝向插管部件的中心枢转。 Cannula member further provided with a fastening means, said fastening means may be in the form of a series of outward hooks, the hooks can be flexed (flexibly) is fastened to the body, in this way the hooks can be inwardly and Center pivot member toward the cannula transfer. 当将插管部件压向基座部件时,这些钩经过这样一个边缘,当这些钩经过该边缘时该边缘朝向中心推动这些钩,并且当这些钩已经经过该边缘时,这些钩返回至其原始位置,并且在这些钩中的一个或多个钩的上表面接触该边缘的下表面时,插管部件不可松脱地锁定至该边缘。 When the cannula member pressed against the base member, so that after one edge of the hooks, when the hooks pass through the edge of the edge toward the center of the push hook, and when the hooks have passed the edge, the hook returns to its original position, and the hooks in one upper or lower surface in contact with the edge of the plurality of hooks, the cannula member not releasably locked to the edge. [0071] 插管部件还可以设置有在本体的相对侧上的导向轨道,所述导向轨道与未示出的连接部件3上的伸出部件对应。 [0071] The cannula member may also be provided with a guide rail on the opposite side of the body of the guide rail and the connecting member 3 (not shown) corresponding to the projecting member. 进一步,设置有隔膜的顶部的开口可以设置有直立边缘,如果使用者希望利用注射器进行液体注射,该直立边缘有助于提供注射位置。 Further, the separator is provided with an opening at the top may be provided with upstanding edge, if the user wishes to use liquid injection syringe, the upstanding edge helps provide the injection site. [0072] 在插管部件被完全插入时,插管部件的紧固装置将所述插管部件锁定至基座部件。 [0072] when the member is fully inserted into the cannula, the cannula member of the fastening device the cannula locking member to the base member. 该紧固装置可包括向外的钩,所述钩可围绕靠近插管部件本体的轴枢转,以这种方式使得当向内(即朝向插管部件的中心)按压所述钩时,可以减小由所述钩的最外边缘形成的直径。 The fastening means may comprise hook outwardly, the hook may pivot about the shaft body close to the cannula member, in such a way that when the inwardly (i.e., toward the center of the cannula member) pressed against the hook, it is possible reduced diameter formed by the outermost edge of the hook. 当移除压力时,由于材料的挠性,这些钩会返回至其原始位置。 When pressure is removed, since the flexible material, the hooks will return to its original position. 当这些钩穿过开口时,这些钩会被向内推动,上述开口例如为开口12B或所述表面板中的对应开口,该对应开口的横截面至少在一个维度上小于所述钩的外边缘,并且,由于这些钩在经过所述开口之后返回至其原始位置,这些钩会将插管部件锁定在插入位置。 When the hook through the opening, the hooks will be pushed inwardly, for example, the opening or openings corresponding to the opening in the surface plate 12B, corresponding to the cross section of the opening is smaller than at least one dimension of the hook on the outer edge and, since the hooks elapsed after the opening returns to its original position, the hooks will lock the cannula member in the inserted position. [0073] 插管部件的本体还可以具有截锥形的形状或轮廓,即,该本体的每个水平横截面都是圆形的并具有不同的直径。 Body [0073] member of the cannula may also have a frustoconical shape or profile, i.e., each horizontal cross section of the body are circular and have different diameters. 该本体还可以设置两个永久性附接的圆形密封件或垫圈。 The body may also be provided two permanently attached circular sealing member or gasket. 开口位于这两个垫圈之间,该开口使得流体能够进入插管部件的内部通孔。 Opening is located between the two washers, the opening such that fluid can enter the interior of the through-hole cannula member. 将插管部件设置在基座部件的一部分(例如连接部件幻中,该部分设置有对应的腔12A,所述腔也具有截锥形的形状。腔12A具有用于流体流至插管或从插管中流出的入口/出口12。[0074] 在基座部件本体的侧表面中的开口与连接部件3的流体路径的开口12之间必须设置密封件。密封件可以是O-形环的形式,S卩,环绕开口12且附接至或被推入连接部件3 的圆柱形管。该密封件可以设置有内支撑件,该内支撑件可以具有圆柱形管的形式。当插管部件被插入开口12A中时,由于插管部件将接触密封件接触并沿所述密封件滑动,因此由于该密封件会由于插管部件本体的紧密配合而扭曲。这种移动会使得密封件被拉出其位置,并且当密封件被拉出其位置时,所述密封件可能引起液体泄露或者导致插入的部件跳回,从而将皮下定位部件拉离期望位置。对该问题的一种解决 The cannula member is provided in a portion of the base member (e.g. coupling member in phantom, the portion 12A is provided with a corresponding cavity, said chamber also having a truncated cone shape having a cavity 12A for fluid flow to or from the cannula outflow cannula inlet / outlet 12. [0074] the opening of the fluid path and an opening member connected to the side surface of the base body member 3 must be provided between the seal member 12. the seal may be ring-shaped O- form, S Jie, surrounding the opening 12 and is attached to the connecting member or pushed into the cylindrical tube 3. the inner seal member may be provided with a support member, the inner support member may have the form of a cylindrical tube when the cannula member 12A is inserted into the opening when, since the contact member cannula seal contacts and slides along the seal, since the seal member so due to a tight fit of the cannula body member distorted. this movement will be such that the sealing member is pulled its position, and when the sealing member is pulled out of its position, the sealing member may cause leakage of liquid or jump back to result in the insertion member, such that the positioning member is pulled away from the desired subcutaneous position. a solution to this problem 案是润滑密封件(例如用硅树脂),或者以别的方法确保密封件非常光滑,第二种解决方案是润滑将要插入的部件, 第三种解决方案是在密封件的下边缘下方设置倾斜的边缘。可以通过如优先权文件的图观中的描绘的那样切割密封件下方的边缘,或者通过切出拐角,并且从而通过将连接部件3的表面“移动”至左边来增加插入部件与密封件下方的连接部件之间的距离,来设置这种开口。[0075] 图2示出了与图1中基座部件相同的实施例,不过在图2中,插入件80附接至用于传感器部件的开口12C的附接装置12D,这是由于可以朝向基座部件的表面向下推动传感器插入件中的在出口处的圆形开口,通过该移动,由于传感器插入件与附接装置之间的摩擦,传感器插入件80的开口与附接装置12C紧密接触。例如在2008年2月7日公开的文献W02008/014792中描述了可以用于将传 The case is lubricated seal (e.g. with silicone), or that the otherwise very smooth seal method, the second solution is to insert the lubricating member, the third solution is disposed below the inclined lower edge of the seal the edges can be cut by as the priority document as FIG concept depicted in the lower edge of the seal, or by cutting the corner, and thus the surface of the connecting member 3 by "move" to the left to increase the sealing member insert the distance between the connecting members below the member to such an opening is provided. [0075] FIG. 2 shows a base member of FIG. 1 in the same embodiment, but in FIG. 2, the insert 80 is attached to a attachment means 12D opening sensor member 12C, which is due to the surface of the base member may be pushed toward the circular opening sensor insertion member at the outlet down, this movement, since the sensor insert and the attachment means friction between the sensor and the opening of the insert attachment means 12C 80 in intimate contact for example may be used to describe the transfer in February 7, 2008 disclosed in document W02008 / 014792 器部件插入根据本发明的基座板中的几种插入件,并且引证方式将这些插入件结合于本文中。[0076] 图3A示出了传感器部件的一个实施例,该传感器部件可以与图1和图2中示出的基座部件1的实施例一起使用。该传感器部件包括要在皮下设置在患者体内的部件;这使得有必要使用插入件或者至少使用插入针。如果可以从患者皮肤表面而不是皮下对传感器部件进行读取,通常这是优选的,但是对于大多数指标(例如胰岛素),已经认识到的是,如果传感器是能够接近患者血液的类型,那么会实现更准确的读取。[0077] 传感器部件包括本体70,所述本体具有沿纵向方向(即,插入方向)的通孔。该通孔使得插入针穿过传感器部件的本体,而同时传感器部件的环绕皮下部件在表面端部处由隔膜73保护,以便防止在使用期间,微生物从该装置的表面进入通孔中。 Insert member according to several base sheet insert in the present invention, and the manner of these inserts reference incorporated herein. [0076] Figure 3A shows an embodiment of the sensor member, the sensor member may FIG. 1 and 2, the base member of Example 1 is shown with the sensor component comprises a member to be disposed subcutaneously patient;. this makes it necessary to use an insert or at least if the insertion needle from the patient's skin. the skin surface rather than reading the sensor member, which is generally preferred, but for most of the indicators (e.g. insulin), it has been recognized that, if the sensor is able to close the patient's blood type, it would be more accurate reading taken. [0077] the sensor 70 includes a body member, said body having a longitudinal direction (i.e., the insertion direction) of the through holes of the through hole such that the needle is inserted through the body member of the sensor, while the sensor member and the skin member around表面端部处由隔膜73保护,以便防止在使用期间,微生物从该装置的表面进入通孔中。用于插入这种传感器部件的插入针需要具有敞口横截面,例如U-形横截面,该横截面包绕皮下传感器部件的周界的一部分,而不是完全环绕皮下传感器部件。传感器部件进一步包括两个触点71, 当传送部装置至基座部件并且该单元处于工作状态时,所述触点确立了与传送部件的电源(例如电池)的电接触。通常,传送部件的电池或电源向泵以及传感器部件提供动力,该泵将流体从储存器传送至插管部件。传送装置通过这些触点向传感器部件提供电流。通常,电源向传感器部件发送电脉冲,且传感器部件会作出反应并且会返回信号(即以电压的形式),作为对从传送装置的电源发送至传感器部件的电脉冲的响应。此外,传感器部件包括伸出的传感器单元72,在使用期间,该伸出的传感器单元将会被插入至皮下,从而该伸出的传感器单元能够接触患者血液。该传感器类型会记录插入部件上的电位差,并且将用于电位差的信号返回至传送装置。传感器部件设置有与插管部件类型相同的固位装置(retention means)230[0078] 可以与根据本发明的基座部件一起使用的插管部件7是已知的,并且从例如W02009/101130(2009年8月20日公开)中的与图4A-图4C、图9A-图9B、图10和图13对应的描述中可以看到对这种插管部件的详细描述。该描述以引证方式结合于此。 [0079] 图:3B示出了传感器部件的第二实施例,该传感器部件可以与根据本发明的基座部件一起使用。该传感器部件包括非传导部件,所述非传导部件具有设置于其上的传导材料层。传感器部件形成有皮下部件f,该皮下部件设置于皮下并且与患者的体液接触。层a、b、c和d表示传导部件,通过这些传导部件可以接触传送装置。层a、b、c和d能够(例如)表示工作电极a、防护层b、参考电极c以及反电极d。可以将传感器部件模制至塑料盖中,这样使得所述传感器部件更容易插入至基座部件中。 [0080] 图4A-图4B示出了图1中基座部件的实施例的两个视图,该基座部件具有位于每个开口12A和12C中的插管部件7和的传感器部件。图4A示出了从基座部件上侧(即背离患者皮肤的侧面)看到的视图,图4B示出了基座部件的侧视图。传感器部件被导向装置12D部分遮挡,在将传感器部件插入至开口12C中时,该导向装置12D有助于插入件的使用者以正确的角度将插入件80定位在正确的位置。在图4B中,能看见在使用期间定位在皮下的部件,即插管22和传感器单元72。 [0081] 图5A-图5C示出了与图1、图2和图4中的基座部件相同的实施例。在图5A-图5C中,通过使用插入件80,已经将传感器部件插入至皮下,不过仍未将插入件从基座部件移除。可以将插入件80从传感器部件释放,并且根据传送装置的该实施例,所述插入件在插入之后需要被移除,以便使使用者/患者能够将传送部件附接至基座部件,并且得到功能齐全的传送装置。 [0082] 图5A以实际大小示出了组合装置(即基座部件将插入件附接至传感器开口12C 的导向装置12D)并且示出了该组合装置的放大部分,该放大部分示出了图5A中的被圈起的部分。在该放大部分中,可以看见在插入件缩回之前与传感器相关的皮下部件是中央传感器部件72和插入针81的结合体,所述中央传感器部件不能自动刺入患者皮肤,所述插入针头部分地包绕中央传感器部件72并且由硬质材料(例如金属或塑料)制成,并且所述插入针具有锋利的或尖头的端部。插入针81的材料足够硬以刺穿患者皮肤,并且为较软的中央传感器部件72的提供皮下位置。插入针81是插入件80的不可松脱的部件,当从基座部件的导向装置12D中移除插入件80时,插入针81也从皮下位置移走。 [0083] 图5B示出了从插入针81的开口侧观察的图5A的组合装置。从该开口侧可以看见传感器的皮下部件72。图5C示出了从插入针81的一侧观察的图5A的组合装置。从该侧可以看出传感器的皮下部件72的一部分,并且可以看见插入针81的尖锐倾斜末端,该插入针81具有敞口横截面,该横截面被描述为U-形横截面,该U-形横截面部分地包绕皮下传感器部件72。 [0084] 图6A-图6B示出了图1中的基座部件和传送部件8在一起的实施例,该传送部件与图IB中示出的传送部件8的类型相同。文中将结合图IB描述图6A和图6B的传送部件。在图6A中,可以看见传送部件8与基座部件相隔较短的距离,所述传送部件恰好位于在使用期间将要附接至基座部件的位置的上方。在图6B中,传送部件附接至基座部件且处于使用位置。图6C示出了与这种组合的传送装置一起使用的手持控制器,通常,这种控制器能够接收从传感器读取并且由传送装置发送的数值。此外,手持控制器一PDA(个人数字助理)一可能能够读取修正设定点,所述修正设定点可被发送至传送装置并且从而控制给患者的药物剂量。该系统提供了具有反馈或闭环控制系统的可能性,其中将分析物(例如葡萄糖)的测量值与用于分析物的设定点进行比较,并且将差值作为启动误差信号返回至传送装置中的控制器,接着计算提供了正确药物(例如胰岛素)量的新输出信号,以便减少误差信号。 [0085] 图7示出了包括传感器的与图1中示出的基座部件相同的实施例。图7进一步描绘了传送部件的触点71a,在使用期间,所述触点形成用于电流和电信号的接触,即,所述触点提供了从传感器至传送部件8的信号路径。触点71a不可松脱地附接至传送装置。传感器部件和触点71a的存在使得能够控制闭环中的传送药物的量,这是因为传感器部件能够提供指明是否达到设定点的信号。触点71具有V形的形式,其中该V形的一个边不可松脱地连接至传送部件,并且在传送部件安装至基座部件上的期间而滑动至使用位置中时,V形的另一个边按压至传感器部件的触点。 [0086] 图8A示出了与图7中相同的实施例,该实施例包括传送装置的触点71a。图8A的侧视图描绘了在使用前的位置中触点71a相对于基座部件的位置,其中传送部件即将在基座部件的导向装置4上滑动,以便建立传送部件的储存器与基座部件的连接部件3之间的流体接触。图8B示出了当所述装置处于预使用位置中时,传送部件相对基座部件的实际位置,其中触点处于图8A中的位置。 [0087] 图9A示出了与图7相同的实施例,该实施例包括传送装置的触点71a。图8A的侧视图描绘了在使用位置中触点71a相对于基座部件的位置,其中传送装置已经在基座部件的导向装置4上滑动,并且已经确立了传送部件的储存器与基座部件的连接部件3之间的流体接触。 [0088] 图9B示出了当所述装置处于使用位置中时,传送部件相对于基座部件的实际位置,其中触点处于图9A中的位置。 [0089] 图10示出了基座部件1的一个实施例,该基座部件具有两个独立插管2¾和22b。该基座部件具有椭圆形形状,并且两个皮下插管能够彼此挨着设置在椭圆形基座部件的一端,或者沿着椭圆形基座部件的纵向轴线相对于彼此移置。为了增加插管出口之间的距离, 插管可以各自以倾斜角度(即0° <a<90°的角度,通常为10° <a<85°的角度)插入。如果插管是倾斜的,将能使插管指向不同方向,并且例如还指向远离皮下定位的传感器部件的方向,从而增加每个出口之间的从倾斜的插管至皮下设置的传感器部件的距离。将插管之间的距离定义为X,并且通常χ有利地具有最小尺寸,该最小尺寸取决于几个因素, 例如使用的插管的类型,例如长度、直径以及材料都很重要,并且此外,将要通过插管供应的药物的种类将决定两个插管之间的必要最小距离。将每个插管与传感器部件72之间的距离定义为1,并且通常y也有利地具有最小尺寸。 y的尺寸由供应的药物对传感器测量结果的影响程度决定,即y取决于供应的药物的种类、传送的药物浓度以及形式、以及例如药物被供应至什么深度、以及传感器在什么深度记录信号。 [0090] 通常,这两个插管不同时向患者传送药物。具有两个插管的目的是能够缩回一个插管,而插入另一个插管,并且仍然使用相同的贴片以及例如相同的传感器。该特征会增加同时包括插管和传感器的贴片的使用寿命,这是因为通常在3天之后就必须缩回插管,而传感器通常可以保持插入6-10天。图10中指明了如何插入插管2¾或者如何已经恰好插入所述插管,而同时或者恰好在插入插管2¾之后,插管22b缩回至这样的程度,即插管22b 不再与之前的插入位置以及患者皮肤接触。 [0091] 图11示出了如何使用如图10所示的装置的顺序步骤。 [0092] 图11A:[0093] 步骤1 :将包括基座部件1的贴片附接至(例如通过已经粘附或焊接至基座部件1 的安装垫2)患者皮肤表面,所述基座部件设置有用于将要利用插入件80插入的至少一个插管22b的开口12C以及用于传感器部件的开口12D。插入件80可以在传送时附接至该贴片,或者使用者可能需要将插入件80定位在贴片上,以便能够插入第一插管22b和传感器。此外,可以使用两个不同的插入件,以用于分别插入第一插管和传感器部件。 [0094] 步骤2 :启动插入件80或分别插入第一插管22b和传感器部件72的两个插入件中的每一个,并且定位皮下部件。之后,移除并且丢弃插入件。 [0095] 图11B:[0096] 步骤3 :现在将包括基座部件1和安装部件的贴片牢固地固定至患者皮肤,并且使主要皮下单元处于工作位置。接着,使用者或患者可将包括储存器、泵送装置以及控制器装置的传送部件8防止在基座部件上,从而使传送装置工作。 [0097] 图11C:[0098] 步骤4:在一段时间(例如2-3天)之后,缩回第一插管22b,并且插入在基座部件内且保持无菌状态的第二插管22a,从而使得贴片还可以再使用2-3天。 [0099] 图12和图13示出了基座部件的一个实施例,该基座部件能够执行以上描述的3 个步骤,不过,本实施例中不需要使用插入件。图12示出了该实施例的三个不同状态。图13首先示出了基座部件的侧视图,接着示出了从上方观察的剖视图,该剖视图使得观察者能够看见该装置内部的流动路径。 [0100] 该实施例包括入口13,来自储存器的药物可以通过该入口进入。该入口还是第二流体路径的入口。入口13由膜17保护,以防止受微生物污染。第二流体路径进一步包括设置有连接针19的连接部件3,并且所述连接针的尖头端由泡形自封闭膜17保护。由于可以在传送装置与基座部件上的入口之间建立的第一流体路径,从而当传送部件附接至基座部件时,经由连接件3将药物(例如胰岛素、其他药物或营养补给)从储存器传送至基座部件,所以位于传送装置内的储存器也可以设置有泡形自封闭膜,该泡形自封闭膜是第一流体路径的一部分。由于这两个部件都设置有自封闭膜,因此能使这两个部件相互独立,并且稍后再重新连接这两个部件,而不需要连接部件3并且从而不会使患者受到污染。 [0101] 来自传送部件中的储存器的流体会通过入口13进入连接部件3 ;连接部件3相对于贴片或者表面板1固定。连接部件3具有用于流体的两个出口,这使得能够建立两条不同的第二流体路径,通过第一出口,可以将流体传送至可移动部件90中的第一入口,并且将流体从该可移动部件90引导至第一插管22a,第二流体路径中的第一条在所述第一插管处结束。通过第二出口,可以将流体传送至可移动部件90的第二入口,并且将流体从该可移动部件90引导至第二插管22b,第二流体路径的第二条在所述第二插管处结束。不过,来自连接部件3的第一出口和第二出口以及可移动部件90的第一入口和第二入口必须位于彼此的正前方,以便将流体从一个单元传送至另一个单元。在图13中,可移动部件90处于中间位置,在该中间位置,流体不会通过任何可能的路径从连接部件3流动至可移动部件90。在连接部件3与可移动部件90之间设置有垫圈94,该垫圈相对于连接部件3固定地定位, 并且可移动部件90沿着垫圈94的表面滑动。由于垫圈94挤压在连接部件3与可移动部件90之间,所以垫圈94可以确保不会有流体从这两个物体之间泄露。 [0102] 图12和图13的实施例还包括用于第一插管2¾的导向装置92,用于第二插管22b 的导向装置93,以及用于传感器部件72的导向装置91。 [0103] 在第一状态(即所述装置进行传送的状态)中,可移动部件90处于中央位置,在该中央位置,当基座部件安装在患者皮肤上时,插管2¾和22b以及传感器部件72都未从基座部件的面向患者的表面伸出。图12A和图13中示出了该状态。 [0104] 在第二状态中,所述装置已经启动,使用者将可移动部件90尽可能地向左推动, 并且第一插管2¾和传感器部件72处于最靠前的位置,而第二插管22b处于完全缩回的位置。由于插管22a由挠性的且能自刺入的材料制成,因此该插管会由于导向装置92所引起的方向变化而以约为45°的角度刺入患者皮肤。此外,传感器部件72由挠性的且能够自刺入的材料制成,该传感器部件由于导向装置91也以期望角度被引导至皮下位置。当所述传感器部件处于其终止位置时,传感器部件的触点能够与传送装置的电子部件传导性接触, 当传送部件安装在基座部件上时建立所述接触。在图13中利用箭头和手指描绘了该状态的启动,并且图12B中示出了由此产生的状态。 [0105] 在第三状态中,使用者尽可能向右推动可移动部件,该移动会将第一插管2¾带动至其完全缩回位置,所述第一插管在该完全缩回位置不与之前的插入位置接触,与此同时由于传感器部件未连接至可移动部件90,所以传感器部件72停留在皮下位置,以这种方式使得所述第一插管会被拉回至其开始位置。第二插管22b被可移动部件90带动至其完全向前的位置,并且由于第二插管22b也由挠性的且能够自刺入的材料制成,所以第二插管22b会在患者皮肤中切出皮下路径,并且导向装置93确定了该路径的方向,在实际实施例中,该方向约为45°。 [0106] 当需要从插入位置移除第二插管时,有必要移除包括皮下定位的传感器部件的整个贴片。可以在患者皮肤上另一位置处用新的基座部件取代该贴片或基座部件,不过传送部件可以重复地用于数个基座部件。 [0107] 图14示出了基座部件的一个实施例的上部的视图,该基座部件设置有用于插管的两个独立位置。独立位置表示两个能够插入插管的位置,这两个位置在插管部件的外边界之间以距离X放置,其中X > 0。 [0108] 图14的左半部分示出了处于第一状态的基座部件1,在该第一状态中已经插入具有插管22b的第一插管部件7。在基座部件1上方示出了传送部件8,所述传送部件已经准备好安装在基座部件1上。该传送部件是可拆卸的,这表示可以根据使用者所愿经常性的将该传送部件紧固至基座部件1并且再次拆下。传送部件8包括储存器6,该储存器6具有连接至连接针19的出口,图14中未示出紧固装置。当对着基座部件1推动传送部件8时, 由于传送部件的连接针19会刺穿插管部件7的顶部开口并且使得流体能够从储存器6流动至基座部件1,因此将形成第一流体路径。第二流体路径由插管壳体内部的开放空间构成,这是由于该开放空间使得将流体从第一流体路径的出口(即连接针19)转移至管状插管22b的开放端,该管状插管嵌入并且固定至插管部件7的本体内部。认为所述开放空间的容积非常小,以致仍然能够得到栓塞式流动(Plug flow)。在该第一状态中,也已经插入传感器部件70,在基座部件1附接至患者皮肤之后,插管部件7和传感器部件70可以利用各自的适于每个部件和位置的插入件来插入,或者在基座部件1附接至患者皮肤之后,利用共同的插入件来插入这两个部件7和70,或者在制造期间,将这两个部件7和70附接至基座部件1,这表示使用者必须设置基座部件1并且在一次操作中插入这两个皮下单元22b 和72。在图14中,传送部件8的透视实施例描绘了如何定位传送部件8的内部部件。传送部件8也包括两个触点71a,所述触点71a创建了用于传感器部件70信号路径,而不考虑传送部件8相对于基座部件1的位置。两个触点71a的其中之一安置在虚设物(dummy) 75 上,该虚设物75支撑着传送部件8,其支撑方式与传感器部件70的方式相同,不过价格更低。 [0109] 图14的右半部分示出了处于第二状态的基座部件1,在该第二状态中具有插管22a的第二插管部件7已经在第二位置插穿了基座部件1中的开口12A。通过使传送部件8相对于左半部分的图示中示出的位置转动180°,就可以得到到达在第二位置处的插管22a的流体路径。即,通过改变传送部件8相对于基座部件1的位置,就能够得到变化的流体路径。不考虑正在工作的插管部件7的位置,通过相同的传感器单元70获取并且发送信号;不过,该传感器部件70通过另一个触点71a连接至传送部件8。 [0110] 图15A和图15B示出了基座部件的一个实施例的侧视图,该基座部件具有用于插管的两个独立位置以及安装在这两个位置的每一个中的传送部件。该实施例中未示出传感器部件。如图4的实施例那样,通过改变传送部件的位置来改变流体路径。在图15A中,传送部件8处于第一状态,其中传送部件8的插管针19刺穿具有皮下插管22b的第一插管部件7中的隔膜,从而提供第一和第二流体路径。在图15B中,传送部件8处于第二状态,其中传送部件8的插管针19刺穿具有皮下插管22a的第二插管部件7中的隔膜,从而提供新的第二流体路径。通过使传送部件8在水平面中相对于基座部件1转动180°,可以得到所述传送部件的第二状态。如果通过挠性管道来提供传送部件8和基座部件1之间的信号路径(该挠性管道例如能够在传送部件8的壳体内卷起),就有可能将传送部件8的储存器连接至超过两个的插管部件7,而同时仍然保持与信号传感器的信号接触。 [0111] 图16示出了基座部件1的一个实施例,该基座部件1结合有用于插管的两个可松脱位置。与每个设有传感器的基座部件一起使用的插管位置的数量可以多于图案中使用的两个插管位置,因此独立位置的数量没有上限。 [0112] 根据该实施例,基座部件1包括接纳部(receiving portion) 14,该接纳部包括用于第一流体路径的未示出的入口。第一流体路径在接纳部14中确立;当连接针19受压穿过封闭接纳部14中的侧面开口(未示出)的保护隔膜,来自储存器6的连接针19使得流体能够进入接纳部14,并且插管连接针M确立基座部件1和皮下定位的插管22b或2¾之间的第二流体路径。将传感器部件70定位在开口12C中,并且根据该传送部件8,将储存器6定位在电子部件和壳体之前并且与其间隔开。 [0113] 当使用者开始使用图16中的实施例时,基座部件1首先通过未示出的安装表面或安装部件定位并且附接至患者皮肤。如果储存器6不是基座部件1的一部分,在将基座部件1固定至患者皮肤之后,使用者可以定位所述储存器。接着使用者在患者皮肤上设置插管位置,当设置有软插管22时,必须利用插入针11定位插管位置,该扎入针可以是手动或自动插入件的一部分。在定位第一插管位置之后,通过压迫插管连接针M穿过容接部14 中的顶部隔膜来确立第二流体路径。通过挠性管将插管连接针M连接至插管位置,来自已经进入接纳部14中的储存器6的药物可以流过该挠性管。在3天之后,或者如果第一插管位置出现例如炎症或泄露的问题,通过将插管连接针M从接纳部14缩回来脱离该位置,此后将该插管位置从患者皮肤移除,接着将具有软插管22a的第二插管位置安装在患者皮肤上,并且通过压迫该插管位置的插管连接针M穿过基座部件1的接纳部14的顶部隔膜,来确立新的第二流体路径。 [0114] 图17、18A和18B示出了基座部件的另一实施例,该基座部件设置有多个插管部件。图17示出了该实施例的剖切侧视图,图18A示出了该实施例的上部视图,并且图18B 示出了耦接部件的放大图,该耦接部件与传送部件一起确立了第一流体路径。 [0115] 根据基座部件的该实施例,通过将移动部件90从中心封闭位置推动至第一或第二位置可以确立第二流体路径,其中可移动部件90的该中心封闭位置使得可以插入两个插管部件7中的任一个。移动部件90是基座部件1的不可松脱的部件,即,所述移动部件不能从基座部件移除,而只能在不同位置之间移动。可移动部件90具有用于流体的入口95 ; 入口95不可松脱地连接至挠性管,该挠性管可移动部件90连接至用于第二流体路径的入口13。入口13在由泡形膜17保护的刺入插管的端部。当传送部件被按压在基座部件上时, 插管将所述膜17刺破,当所述传送部件被按压在基座部件上时,在传送部件的储存器与基座部件之间建立第一流体路径,并且流体能够直接流至可移动部件90,如果可移动部件90 按照图18A中描绘的箭头那样被推动至与插管部件7接触,则流体可以只从可移动部件90 流动至插管部件7。 [0116] 所有实施例的共同点是,基座部件具有用于流体的一个入口以及用于流体的一个或多个出口,即,药物在一个位置通过第二流体路径的入口进入,接着第二流体路径设置有到达一个或多个插管部件的一个或多个出口。通常,在流体已经离开传送部件的被特别保护的储存器6之后,就不再有“储存器”,其中所述储存器在使用之前和使用期间用于储存流体药物,在流体离开该指定储存器6之后,流体以栓塞式流动方式行进,以确保所有流体在基座部件内部具有准确限定的短的停留时间。

Claims (10)

  1. 1.基座部件,所述基座部件能与可拆卸储存器/传送部件结合,所述基座部件(1)包括:紧固装置(15),在使用期间所述紧固装置(1¾将所述储存器/传送部件可松脱地附接至所述基座部件;以及第一流体路径或装置,所述第一流体路径或装置与来自储存器的第一流体路径对应,从而当所述储存器/传送部件附接至所述基座部件时允许所述储存器/ 传送部件与所述基座部件之间的流体流动,所述第一流体路径包括用于当所述可拆卸储存器/传送部件未附接至所述基座部件(1)时中断所述流体流动并且当所述传送部件附接至所述基座部件(1)时打开所述流体路径(19)的装置(17),-所述基座部件(1)还包括下安装表面(¾和一个或多个开口(12A、12C),两个或更多个皮下单元(7、70)延伸穿过所述一个或多个开口,所述两个或更多个皮下单元为至少一个插管和至少 1. The base member, the base member can be combined with the detachable storage / transfer member, said base member (1) comprising: fastening means (15), during use of the fastening means (1¾ the the storage / transfer member may be releasably attached to the base member; and a first fluid path means or the first fluid path or the device and the first fluid path from the reservoir corresponds to when the said storage / transfer means allowing fluid flow between said storage / transfer member with the base member when attached to said base member, said first fluid path when the removable reservoir comprises a when the fluid flow is interrupted / transfer member is not attached to the base member (1) and said fluid path means (19) to open when the transmission member is attached to the base member (1) (17), - the base member (1) further includes a lower mounting surface (¾ and one or more openings (12A, 12C), two or more subcutaneous units (7, 70) extending through the one or more openings, said two or more units of at least a subcutaneous cannula and at least 个传感器部件或者至少两个插管的形式,-第二流体路径,在使用期间允许从所述第一流体路径(19)的出口至皮下定位的插管(22,,22a,22b)的入口的流体流动,以及-信号路径,设置成从所述储存器/传送部件至传感器触点部件,其特征在于,在使用期间所述第二流体路径与皮下定位的插管的端部开口流体连接。 At least one sensor member in the form of two or cannula, - a second fluid path, the cannula during use to allow the first fluid path from the outlet (19) is positioned under the skin (22,, 22a, 22b) of the inlet fluid flow, and - a signal path arranged from the storage / transfer means to contact the sensor member, characterized in that, during use of the end portion of the second fluid path with the cannula positioned opening fluidly connected subcutaneously .
  2. 2.根据权利要求1所述的基座部件,其中,所述第一流体路径由作为所述基座部件的一部分的连接针或者作为所述储存器/传送部件的一部分的连接针以及在其他部分上的用于所述连接针的对应入口形成,所述入口通常由保护性密封膜保护。 The base member according to claim 1, wherein the first fluid path is connected by a pin member as the base or as a part of said storage / transfer member is connected to a portion of the needle and the other the inlet for the corresponding connection pin is formed on the portion of the inlet seal is typically protected by a protective film.
  3. 3.根据权利要求1或2所述的基座部件,其中,所述第二流体路径包括被垫圈环绕的一个表面开口以及被硬质光滑表面环绕的第二表面开口,所述垫圈具有流体能流过的中心开 The base member of claim 1 or claim 2, wherein said second fluid path includes a gasket surrounding an opening in a surface of a smooth surface and a second surface surrounded by a hard opening, the gasket having a fluid energy flows through the center opening
  4. 4.根据权利要求3所述的基座部件,其中,所述第二流体路径包括可移动部件(90),所述可移动部件(90)具有至少两个不同位置,每个位置提供将所述第一流体路径连接至给定插管的独立的第二流体路径。 4. A base member according to claim 3, wherein said second fluid path includes a movable member (90), said movable member (90) having at least two different positions, each providing the said first fluid path coupled to the second fluid path independent given the cannula.
  5. 5.根据权利要求1或2所述的基座部件,其中,所述传送部件(8)具有相对于所述基座部件(1)的多个紧固位置,并且每个位置形成彼此不同的第二流体路径。 The base member of claim 1 or claim 2, wherein the conveying member (8) having a plurality of fastening position relative to the base member (1), and each formed at a position different from each other a second fluid path.
  6. 6.根据权利要求1所述的基座部件,其中,所述插管部件中的一个或多个包括硬质且刚性材料的本体,所述本体具有流体入口和流体出口,所述本体的流体出口与插管的入口端对应。 Said base member 6. The fluid according to claim 1, wherein the cannula or a plurality of components and the body comprises a hard rigid material, said body having a fluid inlet and a fluid outlet, the body outlet corresponding to the inlet end of the cannula.
  7. 7.根据权利要求6所述的基座部件,其中,所述插管部件的插管由柔软且有弹性的材料制成,所述柔软且有弹性的材料例如为弹性体,并且所述插管部件的硬质本体设置有顶部开口。 The base member according to claim 6, wherein said cannula is made of a soft cannula member and resilient material, the soft and flexible material such as an elastomer, and the plug a rigid main body tube member is provided with a top opening.
  8. 8.根据权利要求6或7所述的基座部件,其中,所述基座部件包括用于与每个开口和位置相关的插入件的附接装置以及适于紧固在将所述基座部件安装在患者皮肤上之后插入的每个插管或插管部件或传感器部件的紧固装置。 8. The base member of claim 6 or claim 7, wherein said base member includes a base for the attachment means associated with each opening and the position of the insert and adapted to be secured each fastening means mounting member or cannula or cannula member after insertion of the sensor member on the patient's skin.
  9. 9.根据权利要求8所述的基座部件,其中,在第0天,通过所述基座部件(1)中的开口将一个插管和一个传感器插入,例如同时插入。 9. A base member according to claim 8, wherein, at day 0, by the opening of the base member (1) will insert a cannula and a sensor, for example, inserted at the same time.
  10. 10.根据权利要求8所述的基座部件,其中,用于所述插入件的所述附接装置允许使用者在插入所述插管和/或传感器之后移除所述插入件针,例如与所述插入件的剩余部分一起移除。 10. A base member according to claim 8, wherein said attachment means of the insert for allowing the user to remove the needle after the insert and / or the cannula is inserted into a sensor, e.g. removed together with the remaining portion of the insert.
CN 201080035079 2009-08-07 2010-08-06 Delivery device with sensor and one or more cannulas CN102548598B (en)

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KR20120047896A (en) 2012-05-14 application
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